JP2013513429A - Blood separation system with shielded extraction port and optical control - Google Patents

Abstract

【Task】
A centrifuge comprising a rotor (21), a light source (12), an optical sensor (16), a control system (34), a separation vessel (20), and an optical cell (180) disposed in the separation vessel. Blood separation system. The optical cell has a first extraction port (182) extending radially outward in the optical cell and downstream of the first extraction port and beyond the first extraction port and extends into the optical cell. An erythrocyte extraction port (186); and a dam (192) between the first extraction port and the erythrocyte extraction port and having an upper edge and a lower edge, the first extraction port And the red blood cell extraction port is radially between the upper and lower edges of the dam. Further, the first extraction port includes a hole (216) having a first diameter, a lumen (212) having a second diameter smaller than the first diameter, and a frustoconical shape connecting the hole to the lumen. Passage (214).
[Selection] Figure 11

Description

  This application is related to US Pat. No. 7,605,388, which is incorporated herein by reference. This application claims the priority of currently pending US provisional application 61 / 285,597, filed December 11, 2009.

  Blood collection and processing plays an important role in health care systems around the world. In conventional large-scale blood collection, blood is removed from a donor or patient, separated into various blood components by centrifugation, filtration, or elutriation, and sterile for later infusion into the patient for therapeutic applications. Stored in a container. The separated blood component typically includes a fraction containing red blood cells, white blood cells, platelets, and plasma. Separation of blood into its components can be performed continuously during collection, or can be performed in several batches after collection, particularly with respect to processing of whole blood samples. Separating blood into its various components under highly sterile conditions is extremely important for many therapeutic applications.

  In recent years, many large blood collection centers have employed apheresis blood collection techniques that collect selected blood components and return the remaining blood to the donor during collection. In apheresis, blood is separated into components by online blood processing as soon as it is removed from the donor. Typically, online blood processing is performed by density centrifugation, filtration, or diffusion based separation methods. One or more of the separated blood components are collected and stored in a sterile container, and the remaining blood components are recycled directly to the donor. The advantage of this method is that only selected blood components are collected and purified, allowing frequent blood donations from a single donor. For example, a donor undergoing plateletpheresis where platelets are collected and non-platelet blood components are returned to the donor can be donated every 14 days.

  Apheresis blood processing also plays an important role in many therapeutic procedures. In these methods, blood is drawn from a patient being treated, separated, a selected fraction is collected, and the remainder is returned to the patient. For example, a patient can undergo leukapheresis prior to radiation therapy. In leukapheresis, the leukocyte component of the patient's blood is separated, collected, and stored to avoid exposure to radiation.

  Conventional blood collection systems and apheresis systems typically use differential centrifugation to separate blood into its various blood components. In differential centrifugation, blood is circulated through a sterile separation chamber that rotates at a high rotational speed about a central rotational axis. The rotation of the separation chamber produces a centrifugal force directed in a direction along the rotational separation axis that is oriented perpendicular to the central rotational axis of the centrifuge. The centrifugal force generated during rotation separates particles suspended in the blood sample into separate fractions of different densities. Specifically, the blood sample separates into separate phases corresponding to a high density fraction containing red blood cells and a low density fraction containing plasma. In addition, a medium density fraction containing platelets and white blood cells forms a boundary layer between red blood cells and plasma. Blood centrifuge devices are described in US Pat. No. 5,653,887 and US Pat. No. 7,033,512.

  In order to achieve high throughput and continuous blood separation, most separation chambers are provided with extraction or collection ports. The extraction port is capable of withdrawing material from the separation chamber at an adjustable flow rate and is typically disposed at selected locations corresponding to individual blood components along the separation axis. However, in order to limit the extraction fluid flowing out of the selected extraction port to a substantially single phase, the phase boundary between the separated blood components is aligned along the separation axis so that the extraction port contacts the single phase. Must be placed. For example, if the fraction containing leukocytes is too close to the extraction port corresponding to platelet-rich plasma, the leukocytes will enter the platelet-rich plasma flowing out of the separation chamber, thereby reducing the degree of separation achieved during blood processing. there's a possibility that. Although conventional blood processing by density centrifugation can provide efficient separation of individual blood components, the purity of the individual components obtained using this method may not be optimal for use in many therapeutic applications. Many.

  Based on filtration, elutriation, and affinity-based techniques to achieve the optimal purity required to use blood components as therapeutics, as the use of centrifuge methods alone cannot achieve optimal purity levels Several complementary separation techniques have been developed. However, these techniques often reduce the total yield achieved and may reduce the therapeutic efficacy of the collected blood component. Exemplary methods and devices for blood processing by filtration, elutriation, and affinity based methods are described in US Pat. No. 6,334,842.

  A centrifugal blood component separation device is described, for example, in US Pat. No. 7,605,388 by the same applicant. As described in US Pat. No. 7,605,388, the configuration of the optical cell can extract white blood cells through a first extraction port and plasma and / or platelets through a second extraction port; Red blood cells may be extracted through the third extraction port. As also noted in US Pat. No. 7,605,388 (not shown), the optical cell of the separation chamber can include one or more dams, which are adjacent to each other. In order to facilitate selective extraction of separated blood components with reduced impurities arising from the components, it is placed in close proximity to the extraction port. The use of dams in blood processing by density centrifugation is known in the art and is described in US Pat. Nos. 6,053,856, 6,334,842, and 6,514,189. It is described in the specification.

  The present invention provides methods, devices, and device components for improving the processing of fluids, including fluid components such as blood, blood components, and blood-derived fluids. The methods, devices, and device components of the present invention can monitor and control the separation of blood into components and the collection of selected components after separation.

  In optically controlled blood separation devices, certain transient conditions have been found to cause loss of certain blood components, particularly white blood cells. It has been found that improving the optical chamber from which blood components are extracted from the separation chamber improves the efficiency of white blood cell collection.

  One function of the centrifuge blood processing system described herein can be white blood cell collection. It has been found that the collection of leukocytes is very sensitive to changes in flow conditions. When the pump that controls fluid flow stops, the interface between the red blood cells and the buffy coat generally drops at least temporarily to the level of the red blood cell extraction port. In such an environment, a layer of white blood cells collected at the top of the red blood cell layer is often carried into the red blood cell extraction port and returned to the patient or donor. Because these white blood cells mix with the patient's / donor's total blood volume, they are no longer available for collection unless the patient's blood is effectively reprocessed. These losses can significantly reduce the efficiency of white blood cell collection.

  According to the present invention, the optical cell of the separation container comprises at least a buffy coat extraction port and an erythrocyte extraction port. White blood cells are collected at the buffy coat extraction port. Ramps, dams, and shields direct white blood cells to the buffy coat extraction port. The shield creates a small gap adjacent to the buffy coat extraction port. The red blood cell extraction port is measured along the separation axis along the separation axis by a sufficient radial distance from the rotation axis so that the orifice is positioned between the upper part of the shield and the inclined portion, measured radially from the rotation axis. Extending into the optical cell.

  Such a configuration allows the buffy coat containing leukocytes to be extracted from the optical cell through the buffy coat extraction port for further separation in the fluidized bed filtration chamber. If the flow condition is interrupted, for example by shutting down one or more pumps, the RBC level drops to the level of the RBC extraction port orifice. However, the dams and ramps prevent the buffy coat layer and white blood cells from flowing downstream to the third extraction port, thus allowing white blood cells to be collected for collection when stable flow conditions are reset. Retained.

  In other features of the optical cell, false detection of red blood cells in the first extraction port, which is a condition that can lead to loss of leukocytes that can be collected, is reduced. The extraction port had a stepped lumen. The lumen has a radially outer large-diameter portion and a radially inner small-diameter portion. A large aperture is required to allow a sufficiently large area for optical detection of conditions within the flux monitoring region. In order to facilitate high flow rates through the white blood cell tube, it is necessary that the lumen diameter be small. The volume of white blood cells collected is quite small compared to the volume of red blood cells or plasma processed through the system. If the lumen of the white blood tube is narrow, the possibility of stagnation in the white blood cell line is reduced. Nevertheless, it is believed that white blood cells may be temporarily trapped by fluid vortices through the lumens of prior art designs. White blood cells may continue to accumulate in the vicinity of the lip until the critical volume is removed and passes through the small diameter region of the lumen. If white blood cells accumulate near the flux monitoring area, transmission of light through the flux monitoring area is hindered. The darkness of these areas may be misinterpreted as red blood cells. To alleviate such a condition, the lumen or hole of the first extraction port has a frustoconical taper.

  One form of the apparatus is an optical cell for a separation chamber of a density centrifuge blood processing system for separating fluid components, the optical cell adapted to be mounted on a rotor of the blood processing system, An extraction chamber adapted to transmit at least a portion of the incident optical beam, and extending into the optical cell radially outward relative to the rotational axis of the rotor and transmitting at least a portion of the incident optical beam A first extraction port having holes and orifices through which fluid components are adapted, and downstream of the first extraction port with respect to fluid flowing through the optical cell, the first port A red blood cell extraction port having an orifice extending into the optical cell radially outwardly beyond the orifice of the extraction port; the first extraction port; and the red blood cell And a dam having an upper edge and a lower edge radially outward from the upper edge, the first extraction being between the outlet port and substantially perpendicular to the fluid flowing through the optical cell The orifice of the port and the orifice of the red blood cell extraction port are optical cells that are radially between the upper edge and the lower edge of the dam.

  Another object of the present invention may be to provide an optical cell having a fluid passage disposed radially outward from the dam.

  Yet another object of the invention may be to provide an optical cell having a ramp at the lower edge of the dam, the ramp extending upstream from the dam and beyond the first extraction port. Exists. The inclined portion may extend outward from a joint portion between the inclined portion and the dam. The inclined portion may be substantially flat.

  Another object or form of the invention may be an optical cell having a plate adjacent to the orifice of the first extraction port, the plate being spaced from the orifice.

  In another aspect of the apparatus, the optical cell may have a dam that slopes from an upstream position adjacent to the wall of the optical cell to a downstream position adjacent to the first extraction port.

  Another aspect of the apparatus includes an extraction port, the extraction port in fluid communication with an orifice of the extraction port and having a first diameter, and a second diameter that is less than the first diameter. And a frustoconical passage connecting the hole to the lumen.

  These and other features and advantages of the present invention will become apparent from the following description, drawings, and claims.

FIG. 1 is a schematic diagram of a centrifuge blood separation device having an optical monitoring control system. FIG. 2 is a plan view of the blood component separation container and the piping set. FIG. 3 is a cross-sectional view of the optical cell of the separation chamber. FIG. 4 is a perspective view of the optical cell of FIG. FIG. 5 is a view of an observation area showing a part of the optical cell of FIG. FIG. 6 shows a schematic diagram of an exemplary control system that can control blood processing. FIG. 7 is a perspective view of the optical cell of the present invention with the outer wall removed. FIG. 8 is a plan view of the optical cell of FIG. FIG. 9 is a cross-sectional view of the optical cell taken along line 9-9 of FIG. The outer wall is shown in cross section. FIG. 10 is a cross-sectional view of the optical cell taken along line 10-10 of FIG. FIG. 11 is a cross-sectional view of the optical cell taken along line 11-11 of FIG.

  Referring to the drawings, like numerals indicate like elements and the same number appearing in more than one figure refers to the same element. Further, the following definitions apply herein below.

  The terms “light” and “electromagnetic radiation” are used interchangeably. Light useful in the present invention includes gamma rays, X-rays, ultraviolet light, visible light, infrared light, microwaves, radio waves, or any combination thereof.

  A “separation axis” refers to an axis along which blood components of different densities separate along a density centrifuge. As the separation chamber rotates about the central axis of rotation in the density centrifuge, the centrifugal force is directed in a direction along the separation axis. Accordingly, the plurality of shafts rotate around the central rotational axis of the density centrifuge.

  FIG. 1 schematically illustrates an exemplary embodiment of a blood component separation device 10. The blood component separation device 10 has an optical monitoring system that can measure the intensity of light corresponding to the light pattern generated from the observation region on the separation chamber. The exemplary separation device 10 includes a light source 12, a light collection element 14, and a two-dimensional detector 16. The light source 12 is in optical communication with a density centrifuge 18 that includes a separation chamber 20 that rotates about a central rotational axis 22. The rotation about the central rotational axis 22 separates the blood sample into individual blood components within the separation chamber along a plurality of rotational separation axes oriented perpendicular to the central rotational axis 22. In a preferred embodiment, the separation chamber 20 is held in a circular groove inside the rotor 24 where the separation chamber 20 is located and secured. During operation of the density centrifuge, the rotor is operably connected to the rotating means such that both the rotor and separation chamber rotate about the central axis of rotation 22. In the schematic shown in FIG. 1, the blood sample is divided into an outer high density phase corresponding to the red blood cell component, a medium density phase corresponding to a component containing white blood cells and platelets (eg, buffy coat), and a platelet-rich plasma component. Separated into the corresponding inner low density phase.

  The light source 12 provides an incident light beam 26 that illuminates the observation region 28 on the separation chamber 20. In one embodiment, the light source 12 can generate an incident light beam, a portion of which is transmitted through at least one blood component that is separated in the separation chamber 20. At least a portion of the scattered light or transmitted light 28 from the observation region 28 is collected by the light collecting element 14. The light collection element 14 can direct at least a portion of the collected light 28 onto the two-dimensional detector 16, eg, a digital camera. The two-dimensional detector 16 detects the pattern of scattered light and / or transmitted light 28 from the observation region. In the exemplary embodiment, the two-dimensional distribution of light intensity consists of an image corresponding to the light pattern originating from the observation region 28. In one embodiment, the image of the present invention is a monochrome image, which shows a measure of the brightness of blood components separated along the separation axis. Alternatively, the image of the present invention is a color image, which shows color measurements of blood components separated along the separation axis.

  The observation region 28 is disposed on a portion of the density centrifuge 18, preferably on the separation chamber 20. In the exemplary embodiment illustrated in FIG. 1, separated blood components and phase boundaries between optically distinguishable blood components are visible in the observation region 28. In one embodiment, the observation region is disposed on an optical cell of a separation chamber having a window that transmits the incident beam through the blood sample being processed. In another preferred embodiment, one or more extraction ports (not shown in FIG. 1) are visible in the observation region 28. In another embodiment, the observation region 28 is located at the top of the separation chamber 20 so that blood sample leaks and / or improper alignment of the separation chamber or filler is visible. In yet another embodiment, the observation region 28 is positioned over a portion of the separation chamber so that the composition of separated blood components can be directly monitored. For example, the monitoring system of the present invention provides a method for characterizing the type of cellular component collected and counting the number of cells extracted from the separation chamber as a function of time. Alternatively, the monitoring system is configured to directly measure the concentration of non-cellular blood components such as plasma proteins. In one embodiment, the observation region 28 is configured such that multiple measurements are obtained each time a two-dimensional distribution of scattered and / or transmitted light intensity is measured.

  Optionally, the observation region 28 can be illuminated by a light source 30, which is located on the same side of the separation chamber as the light collection element and the two-dimensional detector. The light source 30 is arranged to generate an incident beam 32 that is scattered by the blood sample and / or the centrifuge. A portion of the light from the light source 30 scattered by the separation chamber is collected by the collection element 14 and detected by the detector 16. The detector 16 can also generate an output signal corresponding to the light intensity or image. In the exemplary embodiment shown in FIG. 1, the two-dimensional detector 16 is operatively connected to a centrifuge device controller 34 that can receive the output signal. The device controller 34 displays the measured intensity distribution, stores the measured intensity distribution, processes the measured intensity distribution in real time, and monitors various optical components and mechanical components of the monitoring system and centrifuge. A control signal is transmitted to the component or any combination thereof. The device controller 34 is operatively connected to the centrifuge 18 and is adapted to flow cellular and non-cellular components exiting the separation chamber, the location of one or more phase boundaries along the separation axis, the center Adjusting the selected operating conditions of the centrifuge, such as the rotational speed of the separation chamber about the axis of rotation 22, the injection of an anticoagulant or other blood treatment agent into the blood sample, or any combination thereof Can do.

  As shown in FIG. 1, the controller 34 can also be operatively connected to the light source 12 or the epi-illumination light source 30. In this embodiment, the device controller 34 and / or the detector 16 can generate an output signal that controls the lighting conditions. For example, the output signal from the detector can be used to control the timing of the illumination pulse, the illumination intensity, the illumination wavelength distribution, or the position of the light source 12 or the epi-illumination light source 30. As also shown in the embodiment illustrated in FIG. 1, the centrifuge device controller and the two-dimensional detector are in two-way communication with each other. In this embodiment, the device controller transmits a control signal to the detector 16 so as to selectively adjust the exposure time and detector gain of the detector and switch between monochrome imaging and color imaging.

  The separation chamber 20 and associated blood component bag and tubing set 40 are illustrated in FIG. The bag and tubing set 40 is intended to be discarded once used, i.e., the separation chamber tubing set is disposable after use for one donor. The pre-connected extracorporeal tubing set 40 may include a cassette assembly 42 and a number of tubing / collecting assemblies 44, 46, 48, 50, 52, 54 interconnected therewith. Preferably, the blood withdrawal / return tubing assembly 44 provides a single needle interface between the donor and the remaining tubing set 40 (a two-needle configuration can also be used but is not shown). At least two lines 56, 58 are provided in the assembly 44 for removing blood from the donor and returning components to the donor. This embodiment includes a cassette assembly 42 that interconnects between a tubing assembly 44 that connects the donor to the cassette assembly 42 and a blood inlet / blood component outlet tubing line subassembly 46. Is done. The subassembly 46 provides an interface between the cassette assembly 42 and the blood processing separation vessel 20. Two piping lines 60, 62, 64, 66 for conveying blood and components to and from the processing vessel 12 are shown in FIG. Anticoagulant tubing assembly 48, vent bag tubing line subassembly 50, red blood cell collection assembly 52, and white blood cell assembly 54 are also interconnected with cassette assembly 42 in this embodiment. As will be appreciated, the external piping circuit or set 40 and blood processing vessel 20 are preferably pre-interconnected to create a pre-sterilized and sealed assembly that is disposable for single use.

  The RBC outlet piping line 62 of the blood inlet / blood component piping assembly 46 begins with the container 20 and is interconnected with the RBC return piping loop 68 through the passage of the cassette 54 assembly 42 to return the separated RBC for donor or collection. Yes. In the case of return, the RBC return piping loop 68 is preferably interconnected to the top of the blood return reservoir 70 of the cassette assembly 42. In the case of sampling, an RBC sampling piping assembly 52 is provided. The RBC collection assembly 52 preferably includes an RBC collection piping line 71 that communicates with one or more RBC collection reservoirs or bags 72 and an air removal bag 74. A blood filter 76 may be provided to remove remaining blood components such as white blood cells.

  In a portion of cassette assembly 42, plasma piping 64 of blood inlet / blood component piping assembly 46 interconnects with pump-engaged plasma piping loop 78 and plasma return piping loop 80. When collecting plasma, a plasma collection bag (not shown) may be provided. Plasma is returned to the donor / patient by plasma return piping loop 80. For these purposes, the plasma return piping loop 80 is interconnected to the top of the blood return reservoir 70 of the cassette assembly 42. One or more types of uncollected blood components, collectively referred to as return blood components, such as red blood cells, plasma or platelets, circulate and accumulate in reservoir 70 and are removed from reservoir 70 during use.

  Major blood components collected in this configuration, like plasma or red blood cells, white blood cells, etc., flow out of the separation chamber 20 through the optical cell 90. This will be described in more detail below. White blood cells accumulate in the filtration chamber 82 and are periodically transferred to the white blood tube 66. White blood cells are pumped through the pump loop 84 and tubing 86 to the white blood collection bag 88 at appropriate intervals. Alternatively, excess blood components can be returned to the donor through a loop 92 connected to the blood return reservoir 70.

  The cassette assembly 42 of the embodiment of FIG. 2 can be mounted and interlocked with the pump / valve / sensor assembly of the blood component separation device 10 in use. Further details of the configuration of the apheresis system, including the mounting and interaction of the disposable assembly 40 with the blood component separation device 10, are described in particular in US Pat. Nos. 5,653,887 and 5,676,644. No. 5,702,357, No. 5,720,716, No. 5,722,946, No. 5,738,644, No. 5,750,025 5,795,317, 5,837,150, 5,919,154, 5,921,950, 5,941,842 And 6,129,656, which are not exhaustively repeated here.

  FIG. 3 is a top view of a prior art optical cell 90 of a separation chamber as described in US Pat. No. 7,605,388. The device 10 of FIG. 1 functions to create an observation area 100 that captures an image of the optical cell 90 as the optical cell passes under the collection element 14. In the viewing area 100, a first calibration marker comprising an edge 102 of the optical cell and a second calibration marker 104 comprising a series of bars 1 mm thick and having known absorption and scattering properties are visible. The first and second calibration markers include a reference for optimizing the focusing of the light collection element, a reference for indicating the position and physical dimensions of a portion of the phase boundary monitoring area, a red blood cell containing component, and a buffy A reference for measuring the position of the phase boundary between the layer and the plasma component.

  FIG. 4 shows a perspective view of an optical cell 90 for monitoring blood processing by density centrifugation as described in US Pat. No. 7,605,388. The present invention includes improvements to such optical cells. The exemplary prior art optical cell 90 includes a blood component extraction chamber 160, a first extraction port 162, a second extraction port 164, and a third extraction port 166. The extraction chamber 160 includes a first side wall 168 and a second side wall 170 that define a blood separation region 172 and blood components are based on density when a centrifugal force field is formed by density centrifugation. To be separated along the separation axis 174. In the embodiment shown in FIG. 4, the extraction chamber 160, the first extraction port 162, and the second extraction port 164 are blood from the blood separation region 172, the first extraction port 162, or the second extraction port 164, respectively. Alternatively, it can pass at least a portion of the light scattered by the blood component. Because the first extraction port 162, the second extraction port 164, and the third extraction port 166 are in fluid communication with different regions of the blood separation region 172 during blood processing, blood components of different densities are different extraction ports. Extracted through.

  As described in US Pat. No. 7,605,388, the configuration of the optical cell 90 can extract white blood cells through the first extraction port 162 and plasma and / or platelets through the second extraction port 164. Red blood cells can be extracted through a third extraction port 166. As also described in US Pat. No. 7,605,388, the optical cell of the separation chamber can include one or more dams that reduce impurities originating from adjacent components. So as to facilitate selective extraction of the separated separated blood components. As mentioned above, the use of dams in blood processing by density centrifugation is known in the art and is described in US Pat. Nos. 6,053,856 and 6,334,842. And in US Pat. No. 6,514,189.

  FIG. 5 shows the observation region 100 of the optical cell 90 of the separation chamber 20. The image of FIG. 5 includes a phase boundary monitoring area 106 of the optical cell and a white blood cell extraction port monitoring area 108. In the phase boundary monitoring area 106, the red blood cell-containing component 110, the plasma component 112, and the mixed phase buffy coat layer 114 having both white blood cells and platelets are visible. The edge 102 of the optical cell comprises a first calibration marker for determining the absolute position of the phase boundary between optically distinguishable blood components. The second calibration marker 104 is useful for optimizing the focusing of the collection element and indicating the position and physical dimensions of the phase boundary region 106 and the white blood extraction port monitoring region 108. The leukocyte extraction port monitoring area 108 includes a first flux monitoring area 116 and a second flux monitoring area 118 disposed on the leukocyte extraction port 119 of the optical cell. In this example according to US Pat. No. 7,605,308, the extraction port 119 has an orifice 121 configured to collect white blood cells in a human blood sample, and a buffy coat of a rotating separation chamber. Extends a distance along the separation axis to terminate close to the layer.

  The intensity of the light transmitted through the first flux monitoring region 116 and the second flux monitoring region 118 varies depending on the concentration of cellular material exiting the separation chamber, the spatial distribution, and the cell type. The intensity of the light transmitted through the first flux monitoring region 116 and the second flux monitoring region 118 is obtained as a function of time and analyzed to examine the composition of cellular material exiting the separation chamber and the characteristics of the flux. It was observed that the cellular material such as leukocytes and erythrocytes absorbs and scatters light from the light source, so that the intensity of transmitted light that is observed decreases as the cellular material passes through the extraction port.

  FIG. 6 shows a schematic diagram of the process control system of blood treatment device 10. The exemplary control system 120 illustrated in FIG. 6 includes a master procedure control system 122 that is in two-way communication with a data acquisition and analysis system 124. The master procedure control system 122 can receive input signals corresponding to the selected blood processing procedure, the processing that the sample undergoes, or the treatment that the patient undergoes. Based on these input signals, the procedure control system 122 generates procedure requests and procedure commands 126 and sends them to the smart slave data acquisition and analysis system 124. The master procedure control system 122 also generates a series of test commands 128 and sends them to the smart slave data acquisition and analysis system 124. The data acquisition and analysis system 124 can receive the test command 128 and generate a test response signal 130 that allows the control system 120 to function well and identify the patient identified by the data acquisition and analysis system 124. Alternatively, it is verified that the blood sample is correctly associated with the selected blood processing procedure or therapy.

  The data acquisition and analysis system 124 includes a first computer processor 132 that is in two-way communication with a second computer processor 134. The first computer processor 132 is configured to receive procedure requests and procedure commands 126 from the master procedure control system 122 and send processing commands 136 to the second computer processor 134. The second computer processor 134 analyzes the processing command 136 and sends a camera setting command 138 to the CCD camera and the focusing element 16. The camera setting command 138 sets the appropriate exposure time, camera and focusing element position, field of view, color or monochrome imaging, and other parameters necessary to obtain a high quality image of the blood processing device. Provide relevant information. The first computer processor 132 is further configured to send illumination control / trigger commands 140 to the light source and camera trigger hardware 142. Using the encoder data regarding the position of the centrifuge, the trigger hardware 142 sends an electronic trigger signal to the light source driver circuit 144 and the camera trigger 146. The camera 16 measures the intensity of light composed of an image of the observation region 100 of the blood processing device. The raw image data is transmitted to the second computer processor 134 for image formatting and real time image processing. In the density centrifugation method, one image is acquired every two rotations of the separation chamber. If the rotational speed is 3000 revolutions per minute, this corresponds to the acquisition of one image every 40 milliseconds.

  The formatted image data is manipulated by the second computer processor 134 using one or more image processing algorithms. The second computer processor 134 extracts measurements from the image data and determines information about the physical and chemical characteristics of the blood component being processed and the operation of the blood processing device itself.

  Immediately after creating a new image data object, the image data object is placed in the linked list of image data objects specified in the image data list 148. This list stores image data information by going back in time. If the acquisition rate is 25 frames per second, 25 image data objects are inserted into the image data list every second. The image data list acts as a managed circular buffer by deleting the oldest image data from the end of the list while inserting the date of the newly acquired image at the top of the list.

  Image data objects in the image data list are periodically examined by the first computer processor 132 to provide an important data set for monitoring and controlling blood processing. The measurements generated by the operation of the image data analysis algorithm set the basis of the image information output signal 150 sent to the master procedure control system 122 and optimize the quality of the image obtained from the analysis. 16, also serves as the basis for the light source and the output signal sent to the camera trigger hardware 142.

  The centrifuge device controller can selectively adjust the position of one or more phase boundaries along the separation axis. For example, the centrifuge device controller adjusts the position of the phase boundary by changing the flow rate of one or more selected blood components exiting the separation chamber. This can be achieved using a pump such as a peristaltic pump to achieve movement in the piping. An inlet pump can be provided that can drive the material out of the separation chamber. The centrifuge device controller may stop the centrifuge upon receipt of a signal indicating leakage of blood components from the separation chamber, separation chamber misalignment, extraction port clots, or similar conditions. The centrifuge controller can coordinate the injection of blood medications, such as anticoagulants, into the blood sample being processed. Alternatively, the centrifuge device controller comprises means for controlling the pumping rate of the material exiting the separation chamber so that the clot at the extraction port can be blown away. For example, upon receiving an image indicating that there is platelet clot at the plasma extraction port, the centrifuge device controller reduces the plasma pumping rate to lower the red blood cell level, and then the plasma The clot can be removed automatically by rapidly increasing the pumping speed and pushing the clot out of the extraction port. Alternatively, the centrifuge controller can selectively adjust the rotational speed of the centrifuge.

Improved Optical Cell Centrifugation controllers and optical systems, as described above, are effective in controlling the operation of a centrifuge blood processing system, but certain transient blood components, particularly those that are subject to certain transient conditions. It is known that white blood cell loss occurs. It has been found that improving the optical cell 90 described above improves the efficiency of white blood cell collection.

  One function of the centrifuge blood processing system described herein can be white blood cell collection. For example, it may be desirable to collect leukocytes from a patient undergoing chemotherapy for cancer so that the patient's own leukocytes can be reinfused into the patient after chemotherapy. The proportion of leukocytes in whole blood is relatively small, and the density of leukocytes is intermediate between plasma and erythrocytes. The optically controlled blood processing system includes plasma and (containing white blood cells and platelets) so that the buffy coat can be removed from the separation vessel 20 through the first extraction port 162 for further processing in the filtration chamber 82. White blood cells are collected by controlling the position of the interface between the buffy coat and the plasma. In the prior art, the opening of the third (red blood cell) extraction port 166 was located deep within the red blood cell layer, generally near the outer wall of the optical chamber. Such a configuration is very effective for collecting red blood cells. However, it has been found that the collection of white blood cells is very sensitive to changes in flow conditions. That is, when the procedure control system 122 stops the pump that controls fluid flow (see above for exemplary reasons for stopping the pump), the interface between the red blood cell and the buffy coat is generally Has been found to at least temporarily drop to the level of the red blood cell extraction port. In such situations, the leukocyte layer collected above the red blood cell layer is often carried into the red blood cell extraction port and returned to the patient or donor. Because these leukocytes mix with the patient / donor's total blood volume, they are no longer available for collection unless the patient's blood is extensively reprocessed. These losses can significantly reduce the efficiency of white blood cell collection.

  An optical cell 180 with improved white blood cell extraction is illustrated in FIGS. The optical cell 180 includes a first extraction port or buffy coat extraction port 182, a second extraction port or plasma extraction port 184, and a third extraction port or red blood cell extraction port 186. When the extraction port is mounted on the rotor of the centrifugal blood separation device, it extends radially inward toward the rotation axis of the rotor. Upstream from the extraction port, the curved surface 188 forms a nozzle that accelerates blood components through the separation chamber 20 toward the extraction port. Downstream of the curved surface 188, white blood cells collect above the red blood cell layer (ie, closer to the axis of rotation). A ramp 190, a dam 192, and a shield 194 direct white blood cells toward the first extraction port 182. The inclined portion 190 is generally a flat sheet and gradually rises toward the rotation axis to lift the buffy coat containing the RBC layer and white blood cells as the blood component approaches the first extraction port. The dam 192 intersects the inclined portion 190 and is inclined toward the extraction port on the downstream side. White blood cells are directed to the first extraction port 182 by the action of blood components flowing around the separation bag 20. The shield 194 includes two walls 196, 198, which are connected to each other and further connected to the inclined portion 190, the dam 192, and the bottom wall 202 of the optical cell 180. The plate 200 serves as a lid for the two walls 196, 198, faces the first extraction port 182, and forms a small gap 204 between the plate 200 and the first extraction port 182.

  The third extraction port or erythrocyte extraction port 186 has a sufficient diameter from the rotational axis so that the orifice 206 exists between the plate 200 and the ramp 190 as measured radially from the rotational axis along the separation axis. Extends into optical cell 180 along the separation axis by a directional distance. The third extraction port 186 is spaced circumferentially downstream from the first extraction port 182.

  The optical cell 180 has a lip 201 that faces radially outward when the separation container 20 is mounted on the blood separator rotor. The lip 201 is in close contact with the flexible outer wall 203 of the separation container. Under the influence of the centrifugal force generated by the rotor, the outer wall 203 follows the shape of the groove in the rotor, thereby creating a space between the ramp 190 and the wall 203. The concentrated red blood cells pass under the slope 190 and accumulate behind the slope 190, dam 192, and shield 194, and can be extracted through the red blood cell extraction port 186.

  Such a configuration allows the buffy coat containing leukocytes to be extracted from the optical cell through the first extraction port for further separation within the filtration chamber 82. If the flow condition is interrupted, for example, by stopping one or more pumps, the RBC level drops to the level of the orifice 206 of the RBC extraction port 186. However, the dams and ramps prevent the buffy coat layer and white blood cells from flowing downstream to the third extraction port, thus allowing white blood cells to be collected for collection when stable flow conditions are reset. Retained.

  In other features of the optical cell 180, false detection of red blood cells in the first extraction port 182 is a condition that causes a suspension of the pump by the procedural control system 122, which can result in loss of collectable white blood cells. Reduced. As shown in FIG. 3, the prior art first extraction port 162 had a stepped lumen 208. The lumen 208 has a radially outer large-diameter portion and a radially inner small-diameter portion, and a lip portion 210 between the two portions. In order to allow a sufficiently large area for optical detection of conditions within the flux monitoring areas 116, 118, a radially outer large aperture is required. In order to facilitate high flow rates through the white blood cell tube 66, it is necessary that the radially inner diameter be small. The volume of white blood cells collected is quite small compared to the volume of red blood cells or plasma processed through the system. If the lumen of the white blood tube 66 is narrow, the possibility of stagnation in the white blood cell line is reduced. Nevertheless, it is believed that fluid swirl through the lumen 208 of the prior art design of FIG. 3 may temporarily trap leukocytes or cell aggregates. White blood cells may continue to accumulate in the vicinity of the lip until the critical volume is removed and passes through the small diameter region of the lumen. If white blood cells accumulate near the flux monitoring areas 116, 118, transmission of light through the flux monitoring areas is hindered. The darkness of these areas may be misinterpreted by the procedure control system 122 as red blood cells. Corrective action by the procedural control system may stop white blood collection or unnecessarily pause the pump. To alleviate such a condition, the lumen or hole 212 (see FIG. 11) of the first extraction port 182 has a second diameter from the first downstream region 216 having the first diameter. It has a frustoconical taper 214 defined by the lumen of the leukocyte tube 66 toward the upstream region 218.

  Accordingly, the improved separation chamber 20 and optical cell 180 reduce the flow condition changes associated with false detection and detection of red blood cells and prevent loss of white blood cells when the flow conditions change, Leukocyte collection is more efficient.

Claims (30)

An optical cell for a separation chamber of a density centrifuge blood processing system for separating fluid components, the optical cell adapted to be mounted on a rotor of the blood processing system,
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first extraction having a hole and an orifice through which a fluid component passes and is adapted to pass through at least a portion of the incident light beam, extending radially outwardly with respect to the rotational axis of the rotor. Port,
An orifice downstream of the first extraction port with respect to fluid flowing through the optical cell and extending radially outwardly beyond the orifice of the first extraction port into the optical cell; Having an erythrocyte extraction port;
A dam that is between the first extraction port and the red blood cell extraction port and is substantially perpendicular to the fluid flowing through the optical cell and has an upper edge and a lower edge radially outward from the upper edge And
The optical cell according to claim 1, wherein the orifice of the first extraction port and the orifice of the red blood cell extraction port are between the upper edge and the lower edge of the dam in the radial direction.   The optical cell according to claim 1, further comprising a fluid passage radially outward from the dam.   2. The optical cell according to claim 1, further comprising an inclined portion at the lower edge of the dam, wherein the inclined portion extends beyond the first extraction port upstream from the dam. Optical cell.   The optical cell according to claim 3, wherein the inclined portion extends outward from a joint portion between the inclined portion and the dam.   The optical cell according to claim 4, wherein the inclined portion is substantially flat.   The optical cell according to claim 3, further comprising a fluid passage radially outward from the inclined portion.   4. The optical cell of claim 3, further comprising a plate adjacent to the orifice of the first extraction port, the plate being spaced from the orifice of the first extraction port. .   2. The optical cell according to claim 1, wherein the dam is inclined from an upstream position adjacent to a wall of the optical cell to a downstream position adjacent to the first extraction port. The optical cell of claim 1, wherein the first extraction port further comprises:
A hole in fluid communication with the orifice of the first extraction port and having a first diameter;
A lumen in fluid communication with the hole and having a second diameter smaller than the first diameter;
An optical cell comprising: a frustoconical passage connecting the hole to the lumen. An optical cell for a separation chamber of a density centrifuge blood processing system for separating fluid components, the optical cell adapted to be mounted on a rotor of the blood processing system,
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first extraction port extending into the optical cell radially outward relative to the rotational axis of the rotor and adapted to transmit at least a portion of the incident light beam;
With
The first extraction port is
Holes and orifices through which fluid components pass;
A lumen in fluid communication with the hole;
A frustoconical passage connecting the hole to the lumen;
Have
The hole is in fluid communication with the orifice of the first extraction port and has a first diameter;
The optical cell, wherein the lumen has a second diameter smaller than the first diameter. A piping set for a density centrifuge blood processing system for separating fluid components,
The piping set is
A separation chamber adapted to be mounted on a rotor of the blood processing system;
An optical cell in fluid communication with the separation chamber;
The optical cell is
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first aperture extending through the optical cell radially outward relative to the rotational axis of the rotor and adapted to transmit at least a portion of the incident light beam and having a fluid component passage and an orifice. An extraction port;
Red blood cell extraction having an orifice downstream of the first extraction port with respect to fluid passing through the optical cell and extending radially outwardly beyond the orifice of the first extraction port into the optical cell. A lower edge that is between the first extraction port and the red blood cell extraction port, is substantially perpendicular to the fluid flowing through the optical cell, and is radially outward from the upper edge and the upper edge. Having a dam,
Have
The piping set, wherein the orifice of the first extraction port and the orifice of the red blood cell extraction port are radially between the upper edge and the lower edge of the dam.   The piping set according to claim 11, wherein the optical cell further includes a fluid passage radially outward from the dam.   The piping set according to claim 11, further comprising an inclined portion at the lower edge of the dam, wherein the inclined portion extends beyond the first extraction port upstream from the dam. Piping set.   The piping set according to claim 13, wherein the inclined portion extends outward from a joint portion between the inclined portion and the dam.   The piping set according to claim 14, wherein the inclined portion is substantially flat.   The piping set according to claim 13, further comprising a fluid passage radially outward from the inclined portion.   14. The piping set according to claim 13, further comprising a plate adjacent to the orifice of the first extraction port, the plate being spaced from the orifice of the first extraction port. Piping set.   12. The piping set according to claim 11, wherein the dam is inclined from an upstream position adjacent to the wall of the optical cell to a downstream position adjacent to the first extraction port. The piping set according to claim 11, wherein the first extraction port further includes:
A hole in fluid communication with the orifice of the first extraction port and having a first diameter;
A lumen in fluid communication with the hole and having a second diameter smaller than the first diameter;
A frustoconical passage connecting the hole to the lumen;
A piping set comprising: A piping set for a density centrifuge blood processing system for separating fluid components, the piping set comprising:
A separation chamber adapted to be mounted on a rotor of the blood processing system;
An optical cell in fluid communication with the separation chamber;
With
The optical cell is
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first extraction port extending into the optical cell radially outward relative to the rotational axis of the rotor and adapted to transmit at least a portion of the incident light beam;
Have
The first extraction port is
Holes and orifices through which fluid components pass;
A lumen in fluid communication with the hole;
A frustoconical passage connecting the hole to the lumen;
Have
The hole is in fluid communication with the orifice of the first extraction port and has a first diameter;
The piping set, wherein the lumen has a second diameter smaller than the first diameter. A rotor adapted to provide centrifugal force to separate blood into blood components;
A light source adapted to selectively illuminate the observation area of the rotor;
An optical sensor adapted to detect light from the light source;
A control system in electrical communication with the rotor, the light source, and the optical sensor, and adapted to control the rotor, the light source, and the sensor;
A separation container mounted on the rotor, in which blood is separated into blood components;
A centrifuge blood separation system comprising: an optical cell in fluid communication with the separation vessel;
The optical cell is
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first extraction having a hole and an orifice through which a fluid component passes and is adapted to pass through at least a portion of the incident light beam, extending radially outwardly with respect to the rotational axis of the rotor. Port,
Red blood cells having an orifice that is downstream of the first extraction port relative to the fluid flowing through the optical cell and extends radially outwardly beyond the orifice of the first extraction port into the optical cell. An extraction port;
A dam that is between the first extraction port and the red blood cell extraction port and is substantially perpendicular to the fluid flowing through the optical cell and has an upper edge and a lower edge radially outward from the upper edge And
The centrifuge blood separation system, wherein the orifice of the first extraction port and the orifice of the red blood cell extraction port are radially between the upper edge and the lower edge of the dam. .   23. The centrifugal blood separation system according to claim 21, further comprising a fluid passage radially outward from the dam.   23. The centrifuge blood separation system according to claim 21, further comprising an inclined portion at the lower edge of the dam, the inclined portion extending beyond the first extraction port upstream from the dam. Centrifugal blood separation system characterized by.   24. The centrifugal blood separation system according to claim 23, wherein the inclined portion extends outward from a joint portion between the inclined portion and the dam.   25. The centrifugal blood separation system according to claim 24, wherein the inclined portion is substantially flat.   24. The centrifugal blood separation system according to claim 23, further comprising a fluid passage radially outward from the inclined portion.   24. The centrifuge blood separation system of claim 23, further comprising a plate adjacent to the orifice of the first extraction port, the plate being spaced from the orifice of the first extraction port. Centrifuge blood separation system.   22. The centrifuge blood separation system according to claim 21, wherein the dam is inclined from an upstream position adjacent to the optical cell wall to a downstream position adjacent to the first extraction port. system. The centrifuge blood separation system according to claim 21, wherein the first extraction port further comprises:
A hole in fluid communication with the orifice of the first extraction port and having a first diameter;
A lumen in fluid communication with the hole and having a second diameter smaller than the first diameter;
A centrifuge blood separation system comprising a frustoconical passage connecting the hole to the lumen. A rotor adapted to provide centrifugal force to separate blood into blood components;
A light source adapted to selectively illuminate the observation area of the rotor;
An optical sensor adapted to detect light from the light source;
A control system in electrical communication with the rotor, the light source, and the optical sensor, and adapted to control the rotor, the light source, and the sensor;
A separation container mounted on the rotor, in which blood is separated into blood components;
A centrifuge blood separation system comprising: an optical cell in fluid communication with the separation vessel;
The optical cell is
An extraction chamber adapted to transmit at least a portion of the incident light beam;
A first extraction port extending into the optical cell radially outward relative to the rotational axis of the rotor and adapted to transmit at least a portion of the incident light beam;
Have
The first extraction port is
Holes and orifices through which fluid components pass;
A lumen in fluid communication with the hole;
A frustoconical passage connecting the hole to the lumen;
Have
The hole is in fluid communication with the orifice of the first extraction port and has a first diameter;
The centrifugal blood separation system according to claim 1, wherein the lumen has a second diameter smaller than the first diameter.

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